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A Phase I Study of Isolated Hepatic Portal and Arterial Perfusion (IHP) With Escalating Dose Melphalan for Primary or Metastatic Unresectable Cancers of the Liver

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001587
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose
Patients with unresectable primary or metastatic cancer confined to the liver will undergo a 1 hour hyperthermic isolated hepatic perfusion (IHP) via the portal vein and hepatic artery with escalating dose melphalan. Patients eligible for this protocol are those with non-colorectal histologies and those with colorectal cancer previously treated with intra-arterial FUDR. Hepatic and systemic toxicity, response to treatment, duration of response, and survival will be followed.

Condition Intervention Phase
Liver Neoplasms Neoplasm Metastasis Procedure: Isolated hepatic portal and arterial perfusion Drug: Melphalan Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study of Isolated Hepatic Portal and Arterial Perfusion (IHP) With Escalating Dose Melphalan for Primary or Metastatic Unresectable Cancers of the Liver

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 30
Study Start Date: September 1997
Estimated Study Completion Date: March 2001
Detailed Description:
Patients with unresectable primary or metastatic cancer confined to the liver will undergo a 1 hour hyperthermic isolated hepatic perfusion (IHP) via the portal vein and hepatic artery with escalating dose melphalan. Patients eligible for this protocol are those with non-colorectal histologies and those with colorectal cancer previously treated with intra-arterial FUDR. Hepatic and systemic toxicity, response to treatment, duration of response, and survival will be followed.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Histologically or cytologically proven measurable primary or metastatic non-colorectal cancer limited to the parenchyma of the liver with no evidence of unresectable extrahepatic disease by preoperative radiological studies.

Limited resectable extrahepatic disease is acceptable.

Patients with colorectal cancer previously treated with intrahepatic arterial infusional therapy using FUDR, those with aberrant arterial anatomy such that infusional therapy is not possible, or those with limited extrahepatic disease such that regional therapy is not indicated will be eligible for this protocol.

Patients must have had no chemotherapy, radiotherapy, or biologic therapy for their malignancy in the month prior to the liver perfusion and must have recovered from all side effects.

Patients must have an ECOG performance standard of 0, 1 or 2 on the day prior to treatment.

Patients must have adequate hepatic function as evidence by bilirubin less than 2.0 and a PT and PTT that are within 1-2 seconds of the upper normal limit.

No patients with biopsy proven cirrhosis or evidence of significant portal hypertension by history, endoscopy, or radiologic studies will be included.

No patients with a history of congestive heart failure with an LVEF of equal to or less than 40% will be included.

No patients with COPD or other chronic pulmonary disease with PFT's less than 50% predicted for age will be included.

Patients must be 18 years of age or older.

Patients must have a platelet count greater than 100,000, a HCT greater than 27.0, a white blood count greater than 3000/ micrograms, and a creatinine less than or equal to 1.5 or a creatinine clearance of greater than 60 ml/min.

No pregnant patients or nursing mothers will be eligible.

Patients must not be taking immunosuppressive drugs or on chronic anticoagulation.

Patients must not have an active infection.

Patients with severe allergic reactions to iodine contrast which can not be controlled by premedication with antihistamines and steroids are not eligible as a hepatic angiogram is needed for this procedure.

Patients must not have HIV disease.

Patients must be aware of the neoplastic nature of his/her illness, the experimental nature of the therapy, alternative treatments, potential benefits, and risks.

The patient must be willing to sign an informed consent.

Patients must not have a history of veno occlusive disease.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001587


Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001587     History of Changes
Other Study ID Numbers: 970200
97-C-0200
First Submitted: November 3, 1999
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
Last Verified: April 2000

Keywords provided by National Institutes of Health Clinical Center (CC):
Hyperthermia
Metastases
Organ Perfusion
Regional Therapy

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Neoplastic Processes
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Melphalan
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs